5.
(a)A wholesale drug distributor shall
designate in writing on a form prescribed by the board a designated
representative for each of the wholesale drug distributor's facilities
licensed under this chapter.
(b)A designated representative shall submit to the board an
application prescribed by the board and provide to the board the
following:
(1)The date and place of birth of the designated representative.
(2)A list of the occupations, positions of employment, and offices
held by the designated representative during the immediately
preceding seven (7) years, including the principal business and
address of the organization with which the occupation, position,
or office was associated.
(3)A statement concerning whether the designated representative,
during the immediately preceding seve
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5. (a) A wholesale drug distributor shall
designate in writing on a form prescribed by the board a designated
representative for each of the wholesale drug distributor's facilities
licensed under this chapter.
(b) A designated representative shall submit to the board an
application prescribed by the board and provide to the board the
following:
(1) The date and place of birth of the designated representative.
(2) A list of the occupations, positions of employment, and offices
held by the designated representative during the immediately
preceding seven (7) years, including the principal business and
address of the organization with which the occupation, position,
or office was associated.
(3) A statement concerning whether the designated representative,
during the immediately preceding seven (7) years, has been
temporarily or permanently enjoined by a court from violating a
state or federal law regulating the possession, control, or
distribution of legend drugs, including details of related events.
(4) A description of any involvement by the designated
representative with a business that:
(A) manufactured, administered, prescribed, distributed, or
stored legend drugs; and
(B) was named as a party in a lawsuit;
during the immediately preceding seven (7) years, including
investments other than the ownership of stock in a publicly traded
company or mutual fund.
(5) A description of any criminal offense of which the designated
representative has been convicted, regardless of whether
adjudication of guilt was withheld or whether the designated
representative pleaded nolo contendere. If the designated
representative indicates that a criminal conviction is under appeal,
the designated representative shall submit to the board:
(A) a copy of the notice of appeal; and
(B) a copy of the final written order of disposition.
(6) A photograph of the designated representative taken within
the immediately preceding thirty (30) days under procedures
specified by the board.
(7) A list of the name, address, occupation, and date and place of
birth of each member of the designated representative's immediate
family, including the designated representative's spouse, children,
parents, and siblings, and the spouses of the designated
representative's children and siblings. Information collected under
this subdivision is confidential.
(8) Any other information required by the board.
(c) A designated representative must have at least two (2) years of
verifiable full-time managerial or supervisory experience in a pharmacy
or with a wholesale drug distributor licensed under this chapter or in
another state. The designated representative's responsibilities must
have included record keeping, storage, and shipment of legend drugs.
(d) A designated representative shall not serve as the designated
representative for more than one (1) wholesale drug distributor facility
at any one (1) time.
(e) A designated representative shall be actively involved and aware
of the actual daily operations of the wholesale drug distributor as
follows:
(1) Be employed full time in a managerial position by the
wholesale drug distributor.
(2) Be physically present at the wholesale drug distributor's
facility during normal business hours, except when absent due to
illness, family illness or death, scheduled vacation, or another
authorized absence.
(3) Be aware of and knowledgeable about all policies and
procedures pertaining to the operations of the wholesale drug
distributor.
(f) A designated representative must complete continuing education
programs specified by the board regarding state and federal law
relevant to the distribution, handling, and storage of legend drugs.
(g) A third party logistics provider must comply with this subsection
until the third party logistics provider has obtained accreditation. A
third party logistics provider must identify to the board a designated
representative who is responsible for the facility's compliance with
applicable state and federal law. The designated representative:
(1) may be a corporate employee or officer, outside counsel, or an
outside consulting specialist with authority to help ensure
compliance;
(2) may be responsible for multiple facilities; and
(3) is not required to be physically present at the facility.